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Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life (NEUROCOG-QOL)

Primary Purpose

Primary Brain Tumor, Neurocognition, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Executive functions
social cognition
quality of life
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Brain Tumor

Eligibility Criteria

8 Years - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 8 and 59
  • Children/adolescents and adults who have been treated by chemotherapy and/or radiotherapy and/or neurosurgery, subsequent to the diagnosis of a primary brain tumor
  • The end of treatment must be comprised between 2 and 5 years at the time of the assessment, as argued above.

Exclusion Criteria:

  • Sensory disturbances (e.g., visual, auditory) incompatible with the achievement of the tasks
  • Language or praxis deficits inconsistent with the achievement of the tasks
  • Neurological disease other than PBT
  • secondary brain tumor
  • Psychiatric history (consultation with a psychiatrist of the University Hospital if doubt)
  • Insufficient French language proficiency

Sites / Locations

  • CHU AngersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

child and adult survivors of brain tumor

healthy controls

Arm Description

Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests. Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)

Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests. Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)

Outcomes

Primary Outcome Measures

performances in executive tasks and executive questionnaires
Executive functions will be assessed using executive cognitive tasks (Stroop task for inhibition, Modified Card Sorting Task for mental flexibility, Digit spans for working memory) and questionnaires (BRIEF for childrens and BRIEF-A for adults) for executive behavioral measures. Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. So, these multiple measurements will be aggregated to determine the number of patients with pathological performances for executive tasks (tasks and questionaires).
performances in social cognition tasks
The first task involves a mental representation or belief about the state of the world (eg, Samson, 2012). The items offered in this kind of task are used to assess the ability to understand that the belief to infer in a type of scenario does not correspond to the reality. The second task will be the Faux Pas task (Stone et al., 1998). This task is composed of written scenarios and the subject must detect if someone has done or said something he should not have said- the "faux pas". If the subject detects that there was a faux pas, additional questions are asked to detect whether he/she understands the cognitive side and the emotional side of the faux pas. Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. These multiple measurements will be aggregated to determine the number of patients with pathological performances.

Secondary Outcome Measures

quality of life questionnaires
Health-related quality of life (HRQOL) will be assessed in adults with the French validated version of the 36-Item Short Form Survey (SF-36; Ware & Sherbourne 1992) and a specific questionnaire for assessing quality of life of patients with brain tumors (QLQ-C30-BN20), commonly used in the international literature (eg, Chen et al, 2012;. Pulenzas et al, 2014). Regarding the HRQOL assessment in children, the choice fell on the Peds-Ql. The PEDS QL measures HRQOL with three major composite assessments -psychosocial, physical, and total HRQOL. Standardized norms in French are available for questionaires, which permit determining if the performances are pathological. These measurements will be aggregated to determine the number of patients with abnormal performances for these questionaires.

Full Information

First Posted
February 5, 2016
Last Updated
May 2, 2018
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02693405
Brief Title
Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life
Acronym
NEUROCOG-QOL
Official Title
Assessment of Executive and Socio-cognitive Functions in Child and Adult Survivors of Primary Brain Tumor: Impact on Patients' and Relatives' Quality of Life.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Significant advances in primary malignant brain tumors (PBT) treatment have led to dramatically improved survival, both in children and adults. However, survival has not come without a cost and aggressive treatment methods associated with significant long-term adverse effects, often referred to as "late effects" (Panigrahy & Blüml, 2009). These effects are the medical, physical, cognitive and psychosocial sequelae associated with cancer and its treatments that generally emerge two to five years after treatment ends (e.g., Landier & Bhatia, 2008). The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One especially important cognitive domain is executive functioning, which refers to essential factors such as problem-solving, goal-directed behavior and the ability to maintain stable interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive impairments on behavioral regulation and quality of life, few studies were conducted with survivors of PBT specifically for the assessment of executive functioning. Another fundamental neuro-cognitive domain is social cognition, which refers to the ability to understand the intentions and beliefs of others (Frith & Singer, 2008). Social cognitive deficits are expected to impair autonomy and relationships, but scarce attention has been devoted to the study of social cognition in survivors of PBT and no study has attempted to compare socio-cognitive data and measures of health-related quality of life. It is noteworthy that executive function and socio-cognitive skills improve throughout childhood and adolescence, and improvements in these skills have frequently been attributed to maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a greater impact of the disease and its treatment on these functions in children/adolescents.
Detailed Description
First, the investigators will calculate the prevalence of cognitive and socio-cognitive deficits, by comparing the performances of patients (children/adolescents and adults) to normative data available for each tasks and to performances of healthy controls matched on socio-demographic criteria. Second, the investigators will compare the neuropsychological scores for cognitive and socio-cognitive tasks to health related quality of life (HRQOL) data (composite scores and by domains). Comparisons of neuropsychological and HRQOL scores will be performed between the two populations (children / adolescents and adults). Third, the investigators will compare the data from the two age groups for the aforementioned variables (cognitive and behavioral executive assessments, cognitive and affective TOM). The proximity of the tasks should provide valid elements of comparison. The investigators will compare the questionnaires in auto-and hetero-evaluation for each HRQOL scales, and also for executive behavioral questionnaires. Finally, to evaluate the investigators will compare the HRQOL patients/relatives' data to measure the potential impact of the disease on HRQOL of relatives of PBT survivors and the potential link between these data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Brain Tumor, Neurocognition, Quality of Life

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
child and adult survivors of brain tumor
Arm Type
Experimental
Arm Description
Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests. Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)
Arm Title
healthy controls
Arm Type
Experimental
Arm Description
Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests. Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)
Intervention Type
Other
Intervention Name(s)
Executive functions
Intervention Description
measures of executive functioning with tasks
Intervention Type
Other
Intervention Name(s)
social cognition
Intervention Description
measures of socio-cognitive functioning with tasks
Intervention Type
Other
Intervention Name(s)
quality of life
Intervention Description
measures of quality of life with questionnaires
Primary Outcome Measure Information:
Title
performances in executive tasks and executive questionnaires
Description
Executive functions will be assessed using executive cognitive tasks (Stroop task for inhibition, Modified Card Sorting Task for mental flexibility, Digit spans for working memory) and questionnaires (BRIEF for childrens and BRIEF-A for adults) for executive behavioral measures. Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. So, these multiple measurements will be aggregated to determine the number of patients with pathological performances for executive tasks (tasks and questionaires).
Time Frame
2 years
Title
performances in social cognition tasks
Description
The first task involves a mental representation or belief about the state of the world (eg, Samson, 2012). The items offered in this kind of task are used to assess the ability to understand that the belief to infer in a type of scenario does not correspond to the reality. The second task will be the Faux Pas task (Stone et al., 1998). This task is composed of written scenarios and the subject must detect if someone has done or said something he should not have said- the "faux pas". If the subject detects that there was a faux pas, additional questions are asked to detect whether he/she understands the cognitive side and the emotional side of the faux pas. Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. These multiple measurements will be aggregated to determine the number of patients with pathological performances.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
quality of life questionnaires
Description
Health-related quality of life (HRQOL) will be assessed in adults with the French validated version of the 36-Item Short Form Survey (SF-36; Ware & Sherbourne 1992) and a specific questionnaire for assessing quality of life of patients with brain tumors (QLQ-C30-BN20), commonly used in the international literature (eg, Chen et al, 2012;. Pulenzas et al, 2014). Regarding the HRQOL assessment in children, the choice fell on the Peds-Ql. The PEDS QL measures HRQOL with three major composite assessments -psychosocial, physical, and total HRQOL. Standardized norms in French are available for questionaires, which permit determining if the performances are pathological. These measurements will be aggregated to determine the number of patients with abnormal performances for these questionaires.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 8 and 59 Children/adolescents and adults who have been treated by chemotherapy and/or radiotherapy and/or neurosurgery, subsequent to the diagnosis of a primary brain tumor The end of treatment must be comprised between 2 and 5 years at the time of the assessment, as argued above. Exclusion Criteria: Sensory disturbances (e.g., visual, auditory) incompatible with the achievement of the tasks Language or praxis deficits inconsistent with the achievement of the tasks Neurological disease other than PBT secondary brain tumor Psychiatric history (consultation with a psychiatrist of the University Hospital if doubt) Insufficient French language proficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Besnard, PhD
Phone
02-41-22-63-71
Email
jeremy.besnard@univ-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Besnard, PhD
Organizational Affiliation
University of Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Le Gall

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18829429
Citation
Frith CD, Singer T. The role of social cognition in decision making. Philos Trans R Soc Lond B Biol Sci. 2008 Dec 12;363(1511):3875-86. doi: 10.1098/rstb.2008.0156.
Results Reference
background
PubMed Identifier
18987046
Citation
Landier W, Bhatia S. Cancer survivorship: a pediatric perspective. Oncologist. 2008 Nov;13(11):1181-92. doi: 10.1634/theoncologist.2008-0104. Epub 2008 Nov 5.
Results Reference
background
Citation
Lezak, M.D., Howieson, D.B., & Loring, D.W. (2004). Neuropsychological Assessment. New York, NY: Oxford University Press.
Results Reference
background
PubMed Identifier
19841424
Citation
Panigrahy A, Bluml S. Neuroimaging of pediatric brain tumors: from basic to advanced magnetic resonance imaging (MRI). J Child Neurol. 2009 Nov;24(11):1343-65. doi: 10.1177/0883073809342129.
Results Reference
background
PubMed Identifier
20434470
Citation
Tamnes CK, Ostby Y, Walhovd KB, Westlye LT, Due-Tonnessen P, Fjell AM. Neuroanatomical correlates of executive functions in children and adolescents: a magnetic resonance imaging (MRI) study of cortical thickness. Neuropsychologia. 2010 Jul;48(9):2496-508. doi: 10.1016/j.neuropsychologia.2010.04.024. Epub 2010 Apr 29.
Results Reference
background
PubMed Identifier
22172909
Citation
Caissie A, Nguyen J, Chen E, Zhang L, Sahgal A, Clemons M, Kerba M, Arnalot PF, Danjoux C, Tsao M, Barnes E, Holden L, Danielson B, Chow E. Quality of life in patients with brain metastases using the EORTC QLQ-BN20+2 and QLQ-C15-PAL. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1238-45. doi: 10.1016/j.ijrobp.2011.09.025. Epub 2011 Dec 13.
Results Reference
background
PubMed Identifier
24510194
Citation
Pulenzas N, Khan L, Tsao M, Zhang L, Lechner B, Thavarajah N, Barnes E, Danjoux C, Holden L, Lauzon N, Sheehan P, Bedard G, Chow E. Fatigue scores in patients with brain metastases receiving whole brain radiotherapy. Support Care Cancer. 2014 Jul;22(7):1757-63. doi: 10.1007/s00520-014-2140-4. Epub 2014 Feb 9.
Results Reference
background
Citation
Samson, D. (2012). Neuropsychologie de la théorie de l'esprit chez l'adulte : Etat de l'art et implications cliniques. In P. Allain, G. Aubin & D. L. Gall (Eds.), Cognition sociale et neuropsychologie (pp. 47-63). Marseille: Solal
Results Reference
background
PubMed Identifier
9802997
Citation
Stone VE, Baron-Cohen S, Knight RT. Frontal lobe contributions to theory of mind. J Cogn Neurosci. 1998 Sep;10(5):640-56. doi: 10.1162/089892998562942.
Results Reference
background
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
background
PubMed Identifier
35230209
Citation
Cantisano N, Menei P, Roualdes V, Seizeur R, Allain P, Le Gall D, Roy A, Dinomais M, Laurent A, Besnard J. Relationships between executive functioning and health-related quality of life in adult survivors of brain tumor and matched healthy controls. J Clin Exp Neuropsychol. 2021 Dec;43(10):980-990. doi: 10.1080/13803395.2022.2040432. Epub 2022 Mar 1.
Results Reference
derived

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Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life

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